Silk garments plus standard care compared with standard care for treating eczema in children: a randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial)

Thomas, K.S. and Bradshaw, Lucy and Sach, Tracey and Batchelor, Jonathan M. and Lawton, Sandra and Mitchell, Eleanor and Harrison, Eleanor F. and Haines, Rachel H. and Ahmed, Amina and Williams, Hywel C. and Dean, Taraneh and Burrows, Nigel P. and Pollock, Ian and Llewellyn, Joanne and Crang, Clare and Grundy, Jane D. and Guiness, J. and Gribbin, Andrew and Cowdell, Fiona and Brown, Sara J. and Montgomery, Alan A. (2017) Silk garments plus standard care compared with standard care for treating eczema in children: a randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial). PLoS Medicine 2017 . pp. 1-23. ISSN 1549-1277

[img]
Preview
PDF - Requires a PDF viewer such as GSview, Xpdf or Adobe Acrobat Reader
Available under Licence Creative Commons Attribution.
Download (1MB) | Preview

Abstract

Background: The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema) is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care) for the management of eczema in children with moderate to severe disease.

Methods and findings: This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1) to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity) was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI), which was log-transformed for analysis (intention-to-treat analysis). A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015): 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94%) children (n = 141 in each group). The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]). Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43). This confidence interval is equivalent to a difference of −1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25%) and 39/141 (28%) of children in the silk clothing and standard care groups, respectively. Even if the small observed treatment effect was genuine, the incremental cost per quality-adjusted life year was £56,811 in the base case analysis from a National Health Service perspective, suggesting that silk garments are unlikely to be cost-effective using currently accepted thresholds. The main limitation of the study is that use of an objective primary outcome, whilst minimising detection bias, may have underestimated treatment effects.

Conclusions: Silk clothing is unlikely to provide additional benefit over standard care in children with moderate to severe eczema.

Item Type: Article
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Identification Number: 10.1371/journal.pmed.1002280
Depositing User: Daunt, Wendy
Date Deposited: 09 Aug 2017 13:07
Last Modified: 13 Oct 2017 00:49
URI: http://eprints.nottingham.ac.uk/id/eprint/44799

Actions (Archive Staff Only)

Edit View Edit View